BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD INLAY LUBRICIOUS COATED DOUBLE PIGTAIL URETERAL STENT

    MDR report key: 3322669 · Received August 28, 2013

    Report

    Report Number
    1018233-2013-06863
    Event Type
    Injury
    Date Received
    August 28, 2013
    Date of Event
    July 26, 2013
    Report Date
    July 29, 2013
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    FAD
    PMA / PMN Number
    K983498
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS FORTH COMING AND THE INVESTIGATION IS STILL IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, IS SUPPLEMENTAL F/U WILL BE MAILED.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT THE STENT BROKE OFF IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421854 BARD INLAY LUBRICIOUS COATED DOUBLE PIGTAIL URETERAL STENT FAD PRODUCTOS PARA EL CUIDADO DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention